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ResourcesHuman Research EthicsPragmatic trials without informed consent? – The Ethics Blog (Pär Segerdahl | April 2019)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Pragmatic trials without informed consent? – The Ethics Blog (Pär Segerdahl | April 2019)

 


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Randomized controlled trials (RCTs) are considered to be the gold standard for determining a causal effect of medical interventions. To achieve this aim, possible confounding factors must be avoided. This implies excluding many patients from participating in the trial, for example, patients with concomitant conditions. A negative consequence of these exclusions, however, is limited generalizability. Studying the artificially uniform participant group, you will be able to determine a causal effect, but you will know much less about real-life treatment outcomes in the population where the intervention actually will be used.

This radical and controversial idea isn’t currently permissible in many jurisdictions (including Australia), but that doesn’t mean it isn’t worth serious discussion.

Further artificiality is created by the written informed consent procedure, which excludes even further patients from participating in the trial. Moreover, because they know they participate in a clinical trial, participants may change their behavior.

All this points to the importance of so-called pragmatic randomized controlled trials. In such trials, the effectiveness of two approved and routinely prescribed medicines are compared in normal clinical practice. This avoids most of the artificiality of RCTs and significantly improves generalizability and practical clinical relevance. Randomization is still required for scientific purposes, however, and written informed consent is an ethical obligation.

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